Visualization of the Stomach During Fasting and Measurement of Intragastric Volume After Ingestion of Fluid: Feasibility and Application of Three Dimensional Ultrasound in Healthy Subjects (ECHO3DGASTRIQ)

Visualization of the Stomach During Fasting and Measurement of Intragastric Volume After Ingestion of Fluid: Feasibility and Application of Three Dimensional Ultrasound in Healthy Subjects. ECHO3DGASTRIQUE Study

Aspiration pneumonia is a dreaded complication of anaesthesia because of its prevalence (1/3,886 cases in elective anaesthesia and 1/895 cases in emergency settings) and its high morbidity and mortality (3 to 9%). This chemical and/or infectious pneumonia is secondary to passage of the gastric contents into the unprotected upper airways during general anaesthesia. The prognosis depends on three factors: the presence of food debris, and the acidity and volume of the gastric contents. To prevent this complication, the French society of anaesthesia and intensive care recommends preoperative fasting rules and, in patients presenting risk factors for aspiration, the use of antacids and rapid sequence intubation. This preventive strategy is associated with certain adverse events: deferred operative procedures, discomfort and hypoglycaemia secondary to fasting, more frequent anaphylactic complications, and memory of anaesthetic induction.

Over recent years, ultrasound has become more widely used by anaesthetists for local anaesthesia, vascular catheterization, haemodynamic monitoring and, more recently, 2D ultrasound estimation of intragastric volume. However, 2D ultrasound estimation of intragastric volume presents several limitations: because of the complex shape of the stomach, this technique requires a long learning curve and the measured volume is poorly correlated with reference techniques (MRI and 99Tc scintigraphy). Two studies have recently measured intragastric volume by three dimensional ultrasound with promising results.

Study Overview

• Status: Completed
• Conditions: Echocardiography, Three-Dimensional
• Intervention / Treatment: Device: 3D echography

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers fasting

Description

Inclusion Criteria:

• Healthy volunteers over the age of 18 years employed by Amiens University Hospital and covered by French national health insurance.
• Fasting (last meal > 6 hours and last drink of water, tea or coffee > 2 hours)
• Signature of the free and informed written consent form.

Exclusion Criteria:

• Pregnant woman.
• Presence of diseases or treatments that alter (slow or accelerate) gastric emptying.
• Presence of swallowing disorders.
• History of gastric or supramesocolic surgery.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
volunteers; Healthy volunteers over the age of 18 years employed by Amiens University Hospital 3D echography	Device: 3D echography; ultrasound visualization of the stomach in fasting patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate of ultrasound visualization of the stomach while fasting	success rate of ultrasound visualization of the stomach while fasting	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ultrasound visualization of the fasting stomach learning curve	ultrasound visualization of the fasting stomach learning curve for each investigator	Day 0
measured difference of antral surface area	antral surface area after ingestion of fluid - fasting antral surface area	Day 0
absolute error of the volume measured	ingested volume - intragastric volume variation	Day 0
relative error of the volume measured	(absolute error / ingested volume) * 100	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Edouard SECQ, PhD, CHU Amiens

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Estimate): June 30, 2016
• Last Update Submitted That Met QC Criteria: June 28, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: fasting; stomach; intragastric volume
• Other Study ID Numbers: PI2012_843_0027